IRB Cases
Cases in Research Ethics
Risking oneself for another is noble; being tricked into running such a risk is to be abused. The ethical issues in research on human subjects were at the core of the modern bioethics movement at its beginning and they remain vexed today. They have been at the heart of the work of the Yale Interdisciplinary Center for Bioethics at least since our fortunate receipt of support from the Donaghue Foundation in 2004.
One part of our work under that grant has been the development of a series of case studies rooted in the work of hospital IRBs in Connecticut. IRB members drafted case narratives reflecting their experience. These were analyzed and discussed with them and our colleagues. Then we have solicited commentaries. The results appear in the cases that follow. We hope that they will be read with profit by IRB members, researchers, and persons otherwise interested in the study of research ethics.
We will eagerly await commentary either on specifics of what the commentators say or on the entire enterprise. We would also be delighted if someone should want to volunteer a case narrative. We can’t guarantee that we’ll use everything submitted, of course, but the field is rich and we’d certainly like a look. Comments either for consideration for publication or just for our information may be submitted to bioethics.center@yale.edu.
Case 1: Payments to subjects who are substance abusers
Comment: Fair compensation or undue inducement?
By Angela Ballantyne, Donaghue Visiting Scholar 2007-2008
Comment: On withholding payments until study completion
By David Smith, Director
Comment: Motives and protection
By R. Douglas Bruce, Assistant Professor of Internal Medicine (AIDS), Yale School of Medicine and Director, South Central Rehabilitation Center
Case 2: Community IRB members’ religious conflict of interest
Comment: “Community” members and conflict
By Robert J. Levine, Senior Scholar in Research Ethics
Comment: Recusal without “conflict of interest”
By Stephen Latham, Deputy Director
Comment: Bias vs. bias
By Ruth Ison, Research Compliance Auditor, Thomas Jefferson University
Case 3: The ability of a biomedical IRB to effectively manage socio-behavioral research
Comment: Diversity and the need for mentoring
By Lois S. Sadler, Assistant Dean for Academic Affairs, Yale School of Nursing
Comment: Controls on novice researchers
By Clair Kaplan, Associate Professor, Yale School of Nursing
Comment: Don't be afraid to ask for help
By Sandra L. Alfano, Chair, Human Investigation Committee I and III, Yale University
Case 4: Public health practice vs. research
Comment: Lines unclear, community key
By Bruce Jennings, Director, Center for Humans and Nature
Comment: Is a new context coming? Who benefits?
By Lauren Taylor, Program Manager, Yale Global Health Leadership Institute
Comment: Is it research or practice?
By Julius Landwirth, Associate Director
Case 5: Reasonable right to privacy for patients accessing hospital services
Comment: Due diligence and 'practicability'
By Chalmers C. Clark, Donaghue Visiting Scholar 2003-2004
Comment: Process, privacy, and PR
By Stephen Latham, Deputy Director
Comment: This time, keep it private
By Susan Bouregy, HIPAA Privacy Officer, Human Research Protection Program, Yale University
Case 6: An ethnographic study of homeless adolescents
Comment: Competence, sampling, and risk to subjects
By Robert Heimer, Professor of Epidemiology & Public Health, Yale School of Public Health
Comment: Protect the researcher, include more subjects
By Adam Schechter, IRB Systems and Compliance Coordinator, Yale University
